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Month: December 2017

Will the Sun Shine All Over Canada? Making Transparent the Financial Relationships of the Medical Industry (Part 2: Towards Effective Transparency)

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By Jean-Christophe Bélisle-Pipon

As detailed in Part 1, Ontario government just enacted the Health Sector Payment Transparency Act, a Canadian first in terms of transparency. The act requires that “transfers of value” (or payments), related to medical products (drugs and medical devices), between a payor and a recipient be reported to the Health Ministry. The Act gives the Ministry unprecedented powers to require, analyze, and publish such data online.

A Transformational Act?

Will this act radically transform the practices and the public knowledge that we have about the financial relations of the medical industry? The effective implementation of the regulations will tell us. However, the fact that Innovative Medicines Canada (formerly known as Rx&D, IMC is the organization representing the interests of the pharmaceutical industry in Canada, like PhRMA in the US) has concerns about the Act is a rather positive sign that this legislation might result into pro-social changes. IMC is invoking both ideological concerns (industry’s interactions with HCPs imply cooperation rather than influence) and logistical concerns (“if the threshold for payments is low, a sales representative could easily lose a receipt and forget to report it”), as well as its  own commitment to limiting undue influences. Read More

The Opioid Crisis Requires Evidence-Based Solutions, Part III: How the President’s Commission on Combating Drug Addiction Dismissed Harm Reduction Strategies

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By Mason Marks

Drug overdose is a leading cause of death in Americans under 50. Opioids are responsible for most drug-related deaths killing an estimated 91 people each day. In Part I of this three-part series, I discuss how the President’s Commission on Combatting Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In Part II I explore how the Commission dismissed medical interventions used successfully in the U.S. and abroad such as kratom and ibogaine. In this third part of the series, I explain how the Commission ignored increasingly proven harm reduction strategies such as drug checking and safe injection facilities (SIFs).

In its final report released November 1, 2017, the President’s Commission acknowledged that “synthetic opioids, especially fentanyl analogs, are by far the most problematic substances because they are emerging as a leading cause of opioid overdose deaths in the United States.” While speaking before the House Oversight Committee last month, the Governor of Maryland Larry Hogan stated that of the 1180 overdose deaths in his state this year, 850 (72%) were due to synthetic opioids. Street drugs are often contaminated with fentanyl and other synthetics. Dealers add them to heroin, and buyers may not be aware that they are consuming adulterated drugs. As a result, they can be caught off guard by their potency, which contributes to respiratory depression and death. Synthetic opioids such as fentanyl are responsible for the sharpest rise in opioid-related mortality (see blue line in Fig. 1 below). Read More

Will the Sun Shine All Over Canada? Making the Financial Relationships of the Medical Industry Transparent (Part 1: Theoretical Transparency)

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By Jean-Christophe Bélisle-Pipon

While Canada is often viewed positively for its public, comprehensive, universal, and accessible health care system, not all is rosy. Canada often lags behind other countries in terms of pharmaceutical policies. Sometimes, this is advantageous (e.g., delaying the approval of a product to wait for more clinical data or real-world efficiency, so to better assess risk-benefit and determining the maximum selling price), but more often simply a problem: until recently, transparency in Canada was more a buzzword than a strong and assumed government stance.

However, a few days ago in Ontario, the omnibus Strengthening Quality and Accountability for Patients Act received royal assent, thus enacting the Health Sector Payment Transparency Act. This clearly marked the beginning of shedding light on the financial relationships and payments to health care providers and organizations made by the medical industry (pharmaceutical and medical device companies), the explicit goal being to strengthen patient trust in the health care system (including research and education activities) by allowing patients to assess whether their health care providers are subject to influence by industry and to foster more informed choice. While the United States enacted the Physician Payments Sunshine Act (PPSA) in 2010, which requires payment disclosure, this is a first in Canada.

The main provisions of the Act Read More

Register Now! The Policy, Politics & Law of Cancer Conference, Feb 8-9, 2018 at Yale Law School

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Introducing Blogger Jean-Christophe Bélisle-Pipon 

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The Petrie-Flom Center is pleased to welcome Jean-Christophe Bélisle-Pipon to the Bill of Health as our newest contributor!

Jean-Christophe is a Visiting Researcher at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School,  a Canadian Institutes of Health Research Postdoctoral Fellow, and a Fellow at the Health Law Institute at Dalhousie University.

A bioethicist by training, he is particularly interested in the marketing of health products and the resulting moral responsibility of regulators and industries. While his undergraduate studies in physics led him to pure science, his interest in the field of health and bioethics grew during his experiences in the pharmaceutical industry, where he worked for 6 years in clinical research and regulatory affairs, as well as in business intelligence, sales, and marketing.

His research also focuses on patient engagement in research by exploring ethical and logistical dimensions as well as providing guidance for capacity development of future researchers. Jean-Christophe is also interested in how researchers can engage the general public to reflect on the most pressing ethical issues of our time, including by mingling arts and bioethics to advance these reflections in the public space. He will be the new Managing Editor of the Journal of Law and the Biosciences beginning January 2, 2018.

Welcome, Jean-Christophe!

Considering Direct-to-Consumer Genetic Testing? Spit with Caution

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By Gali Katznelson

A friend and I had been vaguely entertaining the idea of ordering genetic testing kits for some time. Then, Black Friday happened. My friend called me to share that 23andMe was on sale, 50% off, for 1 more hour! Typing our credit card information into Amazon, we tossed around some half-reasoned arguments in favor of our impulsive purchases: “this’ll be a fun science experiment”, “what if we catch something preventable in time to make lifestyle changes?” and, “we really should be contributing our data to research for the public good.” Within minutes, two kits were ordered and thanks to the magic powers of Amazon Prime, these boxes appeared on our doorsteps within days. Few things in life are as exciting as receiving a mail delivery, but as we unwrapped our packages, finding the words “Welcome to You” plastered on our shiny white Pandora’s boxes, somehow our excitement began to dwindle. One month later, our boxes remain unopened.

Genetic testing is clearly something we should have given more thought before the marketing geniuses got the best of us. Here are some questions anyone considering taking a direct-to-consumer (DTC) genetic test should answer (ideally before buying the test):

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Andrea Matwyshyn on ‘The Week in Health Law’ Podcast

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By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

A special holiday, near-double episode of TWIHL, featuring a return visit from Andrea Matwyshyn, Professor of Law at Northeastern University, co-director of NEU law school’s Center for Law, Innovation, and Creativity (CLIC), and a US-UK Fulbright Commission Cyber Security Scholar (2016-2017). In addition to her appointment on the law faculty, she is a professor of computer science (by courtesy).

The episode focused on AI, regulation of cutting edge medical devices, and security. We mentioned, in passing, explainable AI, European regulation to require it in certain settings, the general problems raised by AI in health care, and recent developments regarding both mental health apps and devices. Andrea developed her idea of the “Internet of Bodies,” making a compelling case that the law of software liability needs to evolve to address the high stakes of software failure in critical medical devices. We concluded with some year-end reflections on the annus horribilis we shall gladly bid adieu in 10 days. In the meantime, happy holidays to all our listeners!

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

Civil Commitment and the Opioid Epidemic: A Call for Research

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By Scott Burris, JD

There is a lot of interest in civil commitment these days, as a possible tool to fight two big health problems. As we continue to watch the rates of opioid-related deaths climb, and in the wake of an unfunded emergency declaration by President Trump, some policymakers are looking to involuntarily commit overdose survivors for drug treatment. On the gun violence side, experts like Jeffrey Swanson have argued for applying gun-access restrictions that now cover people subject to long-term civil commitment to those subjected to short-term civil commitment.

With those kinds of ideas in the air, it is important to recognize how little modern data we have on commitment and its effects. In a recent article in the Washington Post discussing commitment for opioid treatment, Michael Stein and Paul Christopher emphasize how little we know. I entirely agree on the need for more research, and offer a couple of things to help.

The first is the Policy Surveillance Program’s LawAtlas dataset that maps civil commitment laws across all 50 states and the District of Columbia. If we’re going to examine these laws and their impact, this is the place to start. We also put out the call to anyone interested in studying this to work with us not only to update this data through 2017, but also to make sure we’re mining these laws and their characteristics for the right information in these circumstances — Are we asking the right questions? Read More

The Opioid Crisis Requires Evidence-Based Solutions, Part II: How the President’s Commission on Combating Drug Addiction Ignored Promising Medical Treatments

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By Mason Marks

Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids kill an estimated 91 Americans each day and are responsible for most drug-related deaths in the US. This public health crisis requires solutions that are supported by science and reason instead of emotion and political ideology. In Part I of this three-part series, I discuss how the President’s Commission on Combating Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In this second part of the series, I explore how the Opioid Commission ignored medical interventions that are used successfully in the U.S. and abroad. In Part III, I will discuss non-medical interventions such as drug checking and safe injection sites. The Commission’s failure to consider these options is likely driven by emotions such as fear and disgust rather than a careful review of scientific evidence.

Medical marijuana is currently accepted in 29 U.S. states and the District of Columbia. It is also permitted in at least 10 countries. However, the Opioid Commission outright rejected calls to consider the use of medical marijuana as an alternative to opioids for managing pain. Prior to the Commission’s first meeting, it solicited input from industry and members of the public on how to address the opioid crisis. In response, it received over 8,000 public comments. According to VICE News, which obtained the documents by submitting a Freedom of Information Act (FOIA) request, most comments were submitted by individuals urging the Commission to “consider medical marijuana as a solution to the opioid epidemic.” A spokesman for the Office of National Drug Control Policy, a body of the Executive Branch that provides administrative support to the Opioid Commission, reports receiving “more than 7,800 public comments relating to marijuana.” Despite these comments, in its final report, the Commission dismissed the notion that marijuana should play a role in treating chronic pain and opioid addiction. Its report cited a recent study from the American Journal of Psychiatry, which concluded that marijuana use was associated with an increased risk of opioid abuse. However, this study relied on data that was collected over twelve years ago. One of its authors, Columbia Medical School Professor Mark Olfson, told CNN that if the data were collected today, they could yield different results.

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Save the Date, April 12-13, 2018! Diseases of Despair: The Role of Policy and Law

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Diseases of Despair imageDiseases of Despair: The Role of Policy and Law
April 12 – 13, 2018
Various locations – check agenda for details
Northeastern University, Boston, MA

Description

Anne Case and Angus Deaton shocked the world with their 2015 report that noted an increase in all-cause mortality among middle-aged white non-Hispanic men and women in the United States. This pattern is not occurring in other groups within the United States and Europe. Their report, and others since then, have linked this trend to so-called deaths of despair (death from suicide, chronic substance use, and overdoses) and their linkage to other determinants of health (education, labor markets, marital patterns). A recent update to the report makes it clear that this trend is no longer limited to any particular geographic region within the United States.

This year’s NUSL Center for Health Policy and Law annual conference and associated scholarship will bring together experts, policymakers, and academics to discuss the causes behind such trends, and to explore potential political, policy, and legal responses for addressing broader determinants that affect the physical and mental health of Americans dying from these diseases of despair. Deeper examination into similar patterns among diverse populations, as well as analysis of continuing racial, ethnic, and socioeconomic disparities, will be central to the discourse.

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